Tagare 2013.
Study characteristics | ||
Methods | RCT | |
Participants | 114 preterm neonates (< 37 weeks') with respiratory distress (Silverman score > 3) up to 6 hours after birth treated with nasal CPAP 6 to 7 cm H₂O (as primary support) | |
Interventions | Bubble (Fisher & Paykel): N = 57 Ventilator (Bear Cub 750): N = 57 Short binasal prongs were used in both groups. |
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Outcomes | Treatment failure (worsening respiratory distress with FiO₂ > 0.6 and CPAP > 8 cm H₂O, recurrent apnoea, "shock", requiring endotracheal intubation and mechanical ventilation) Mortality before hospital discharge Duration of CPAP use Pneumothorax Nasal trauma (skin erosion/septal injury) |
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Notes | Setting: Pune, India (2008 to 2009) Funding: not stated |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer generated |
Allocation concealment (selection bias) | Low risk | Sealed, coded envelopes |
Blinding (performance bias and detection bias) All outcomes | High risk | Open‐label |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Outcome reporting complete. |
Selective reporting (reporting bias) | Low risk | Unlikely (comprehensive) |
Other bias | Low risk | No evidence of an imbalance in baseline demographics |